Assessment of Blood Glucose Monitoring Devices With New Insight Features

• Sponsor: LifeScan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02929654
• Collaborator: (none)
• Enrollment: 267
• Locations: 3
• Arms: 3
• Actual Duration (Months): 8.7
• Patients Per Site: 89
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

To investigate whether novel insight features in new BGMs can improve glycemic control.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: OneTouch Verio®; Device: OneTouch Verio® Flex; Device: Subject's Own Blood Glucose Meter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 267 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jun 22, 2017
• Actual Study Completion Date: Jun 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.	Device: Subject's Own Blood Glucose Meter; Subject's Own Blood Glucose Meter
Experimental: OneTouch Verio® Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks	Device: OneTouch Verio®; Colour Enhanced Blood Glucose Meter.
Experimental: Intervention 02 Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.	Device: OneTouch Verio® Flex; Colour Enhanced Blood Glucose Meter.

Outcome Measures

Primary Outcome Measures

1. A1c change from baseline after 12 weeks [12 weeks]

   A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria Summary:

• Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening

• Currently performing SMBG at home for diabetes management decisions

• Willingness to notify the study staff if they become pregnant during the study

• Willing to sign an informed consent

Exclusion Criteria Summary:

• Is unlikely to be compliant with the diabetes regimen in the opinion of study staff

• Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn

• Conflict of Interest

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Centre, Heartlands Hospital	Birmingham		United Kingdom	B9 5SS
2	NHS Lothian	Edinburgh		United Kingdom	EH16 4SA
3	Highland Diabetes Institute	Inverness		United Kingdom	IV2 3JH

Sponsors and Collaborators

• LifeScan

Investigators

• Study Director: Mike Grady, LifeScan Scotland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LifeScan
• ClinicalTrials.gov Identifier: NCT02929654
• Other Study ID Numbers: 3150067
• First Posted: Oct 11, 2016
• Last Update Posted: Aug 15, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Aug 15, 2017